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. 2022 Dec 1;4(12):e0808.
doi: 10.1097/CCE.0000000000000808. eCollection 2022 Dec.

Multistudy Research Operations in the ICU: An Interprofessional Pandemic-Informed Approach

Deborah J Cook  1   2   3   4 , Erick H Duan  1   2   3   4 , France J Clarke  3   4   5 , Karlo Matic  4 , Sarah Culgin  4 , Laurel Kelly  6 , Katlynne S Nelson  4 , Christine V Wallace  7 , Mark D Soth  1   2 , Kimberley A Lewis  1   2   4 , Jill C Rudkowski  1   2 , Dan Perri  1   2 , Tania L Ligori  1   8 , Roman Z Jaeschke  1   2   3 , Zain Chagla  2 , Dipayan Chaudhuri  1 , Angela E Wright  7 , Zoe Y Fu  7 , Brenda K Reeve  1   8   9 , Hilary M Lee  1   9   10 , Jeffrey D Overington  1   8 , Anna Rozenberg  1   9 , Kimberly A Bloomfield  1 , Katryn Love  1 , Jennifer L Gain  5 , Nicole L Zytaruk  3   4 , Jason H Cheung  2 , Lehana Thabane  4   11 , Michelle E Kho  1   4   6   12
Affiliations

Multistudy Research Operations in the ICU: An Interprofessional Pandemic-Informed Approach

Deborah J Cook et al. Crit Care Explor. .

Abstract

Proliferation of COVID-19 research underscored the need for improved awareness among investigators, research staff and bedside clinicians of the operational details of clinical studies. The objective was to describe the genesis, goals, participation, procedures, and outcomes of two research operations committees in an academic ICU during the COVID-19 pandemic.

Design: Two-phase, single-center multistudy cohort.

Setting: University-affiliated ICU in Hamilton, ON, Canada.

Patients: Adult patients in the ICU, medical stepdown unit, or COVID-19 ward.

Interventions: None.

Measurements and main results: An interprofessional COVID Collaborative was convened at the pandemic onset within our department, to proactively coordinate studies, help navigate multiple authentic consent encounters by different research staff, and determine which studies would be suitable for coenrollment. From March 2020 to May 2021, five non-COVID trials continued, two were paused then restarted, and five were launched. Over 15 months, 161 patients were involved in 215 trial enrollments, 110 (51.1%) of which were into a COVID treatment trial. The overall informed consent rate (proportion agreed of those eligible and approached including a priori and deferred consent models) was 83% (215/259). The informed consent rate was lower for COVID-19 trials (110/142, 77.5%) than other trials (105/117, 89.7%; p = 0.01). Patients with COVID-19 were significantly more likely to be coenrolled in two or more studies (29/77, 37.7%) compared with other patients (13/84, 15.5%; p = 0.002). Review items for each new study were collated, refined, and evolved into a modifiable checklist template to set up each study for success. The COVID Collaborative expanded to a more formal Department of Critical Care Research Operations Committee in June 2021, supporting sustainable research operations during and beyond the pandemic.

Conclusions: Structured coordination and increased communication about research operations among diverse research stakeholders cultivated a sense of shared purpose and enhanced the integrity of clinical research operations.

Keywords: clinical research; critical care research; pandemic; randomized trials.

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Conflict of interest statement

Dr Cook holds a Canada Research Chair from the Canadian Institutes for Health Research. Dr. Lewis holds the Constantine Douketis New Researcher Award from the Research Institute of St. Joseph’s Healthcare Hamilton. Dr. Kho holds a Canada Research Chair from the Canadian Institutes for Health Research. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Figures

Figure 1.
Figure 1.
Timelines for pursued, paused, and launched academic randomized trials. In this figure, we display the periods during which these randomized trials were operational during the first three pandemic waves. BALANCE = Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness, CATCO = Canadian Treatments for COVID-19, CONCOR-1 = CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness, CORONA = COvid pRONe hypoxemiA: Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals, COVI-PRONE = Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19, CYCLE = A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients, FAST = The Frequency of Screening and SBT Technique Trial, FISSH = Fluids in Septic Shock, LOVIT = Lessening Organ Dysfunction With VITamin C, LOVIT-COVID = Lessening Organ Dysfunction With VITamin C-COVID-19, RCT = randomized clinical trial, REMAP-CAP = Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia, REVISE = Re-EValuating the Inhibition of Stress Erosions.
Figure 2.
Figure 2.
Total trial enrollments. In this figure, we show enrollments in these randomized trials. Several patients were enrolled in two or more trials during this period. BALANCE = Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness, CATCO = Canadian Treatments for COVID-19, CONCOR-1 = CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness, CORONA = COvid pRONe hypoxemiA: Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals, COVI-PRONE = Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19, CYCLE = A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients, FAST = The Frequency of Screening and SBT Technique Trial, FISSH = Fluids in Septic Shock, LOVIT = Lessening Organ Dysfunction With VITamin C, LOVIT-COVID = Lessening Organ Dysfunction With VITamin C-COVID-19, RCT = randomized clinical trial, REMAP-CAP = Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia, REVISE = Re-EValuating the Inhibition of Stress Erosions.
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